Genetic and Biohumoral Factors Involved in Menière's Disease and Their Correlation With Phenotypes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
Aim of this work was to assess the role of polymorphisms belonging to genes involved in the regulation of ionic homeostasis in Caucasian patients with Ménière Disease (MD) and compare results with a cohort of patients affected by vestibular migraine and a cohort of non vestibular subjects
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with definite Menière's Disease according to the criteria of the Barany Society
Disqualifiers
surgically treated before the examination or if they had undergone intratympanic therapy with steroids or gentamicin
Trial population
Patients were included if they fulfilled criteria for definite unilateral MD according to the Barany Society; in subjects enrolled before 2015 a retrospective analysis of data confirmed Barany criteria
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
a blood withdrawal will be obtained
GeneticA blood withdrawal will be obtained to assess
blood withdrawal
GeneticGenetics of ionic transporters and biohumoral factors related to Meniere's Disease and differences with vestibular migraine subjects
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: Menière's Disease; vestibular migraine2 interventions
Group B: Menière's Disease (MD)2 interventions
Group C: Vestibular Migraine (VM)2 interventions
Trial outcomes
Primary outcomes
1
Genetic of ionic transporters
Genomic DNA of all cases and controls was extracted from venous blood by standard methods. 36 Single Nucleotide Polymorphisms (SNPs) were genotyped using TaqMan® OpenArray™ Genotyping System (Life Technologies, Foster City, CA). All DNA samples were loaded and amplified according to the manufacturer's instructions.
Time frame
From enrollment to the end of enrollment in december 2027Secondary outcomes
1
Biohumoral factors specifically Interleukins, Endogenous Ouabain
Values of interleukins and endogenous ouabain is evaluated in blood sample of patients and compared with values in blood samples of a control group and in patients with vestibular migraine
Time frame
From enrollment to the end of the study in july 2027Sponsors and contacts
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Source ClinicalTrials.gov